Focused ultrasound is cleared to treat liver tumors in the United States.
The US Food and Drug Administration (FDA) has cleared HistoSonics’ novel therapy platform – called EdisonTM – to treat liver tumors. EdisonTM uses histotripsy to noninvasively destroy tissue in the liver and is the first and only such platform available in the US. This is also the first time the use of histotripsy has earned regulatory approval worldwide. Read More
Focused Ultrasound Therapy
Focused ultrasound is a rapidly evolving, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with liver tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.
How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated.
One mechanism is the production of precise ablation (thermal destruction of tissue). This destruction can be done to completely destroy the target or to partially treat it, and partial treatment is believed to stimulate the patient’s immune response, which may have a broader impact.
Another mechanism is the use of mechanical (non-thermal) histotripsy to destroy the tumor.
A third mechanism is to use focused ultrasound to cause hyperthermia which enables the local release and absorption of a therapeutic that is contained in the blood stream.
A fourth mechanism is to use Boiling Histotripsy to destroy the targets in the liver. This has the advantage that it may be useful as a ‘bridging’ technique to treat the patient and may also help in the regrowth of non-fibrous tissue, as the patient is waiting for a liver transplant. While this has had success in animal models, it has not yet been transferred to human treatment.
Advantages
The primary options for treatment of liver tumors include surgery, chemotherapy, radiotherapy, localized destruction of the tumor tissue (via radiofrequency ablation, alcohol injection, cryosurgery, or laser photocoagulation), or combination of two or more of these options. The long-term solution for primary liver cancer is often liver transplantation.
For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. Focused ultrasound can also enhance the chemotherapy dose for the target, with less impact to the rest of the patient.
Clinical Trials
A clinical trial in the UK is recruiting patients with colorectal cancer and metastasis to the liver. It uses focused ultrasound to activate a microbubble preparation designed to improve the penetration of chemotherapy to the liver.
An observational clinical trial is being done on patients treated with the Histosonics’ Edison device looking for long term outcomes for the patients treated.
A clinical trial is treating colorectal cancer metastasis with to the liver with the Histosonic’s Edison device in Ohio.
The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/.
See a list of treatment sites >
See a list of laboratory research sites >
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Regulatory Approval and Reimbursement
In October 2023, the US Food and Drug Administration cleared HistoSonics’ Edison device to noninvasively treat liver tumors using histotripsy.
A focused ultrasound system has been approved in China, Russia, Europe, and Korea for treatment of liver cancer.
To the best of our knowledge, the use of focused ultrasound to treat liver cancer is not yet widely reimbursed by medical insurance.
Notable Papers
Yu Y, Yan X, Gui Y, Lv K, Jiang Y. Prospects for clinical translation of histotripsy in liver applications: a systematic review based on preclinical studies. Quant Imaging Med Surg. 2026 Jan 1;16(1):92. doi: 10.21037/qims-2025-1137. Epub 2025 Dec 31. PMID: 41522007
Sarkar AR, Sahoo R, Jana NR. Ultrasound-Responsive Perfluorohexane Nanodroplets for Cell-Targeted Histotripsy and Therapy. ACS Appl Bio Mater. 2026 Feb 2;9(3):1311-1321. doi: 10.1021/acsabm.5c01590. Epub 2026 Jan 8. PMID: 41505765
Anthony GJ, Sammet S, Souris JS, Bader KB. Histotripsy-mediated reactive oxygen species generation in vitro. Ultrasonics. 2026 Mar;159:107885. doi: 10.1016/j.ultras.2025.107885. Epub 2025 Nov 9. PMID: 41240873
Yang Y, Zhang H, Shen Y, Yang F, Zhao D, Lin Y, Huang G. High-intensity focused ultrasound in the multimodal treatment of colorectal cancer liver metastases: A case report. Oncol Lett. 2026 Jan 7;31(3):98. doi: 10.3892/ol.2026.15451. eCollection 2026 Mar. PMID: 41551343
Wehrle CJ, Sayed Ahmed AF, Knott E, Hong H, Uysal M, Schlegel A, Berber E, Walsh RM, Kim J, Aucejo F, Kwon DCH. The first full year of histotripsy for liver tumors: Local tumor control and preliminary oncologic efficacy. Surgery. 2025 Dec 5:109898. doi: 10.1016/j.surg.2025.109898. PMID: 41353073
Rohfritsch A, Griffon A, Olhagaray E, Biénassis A, Barrot L, Muleki-Seya P, Melodelima D. Impact of focused ultrasound on the cellular network of liver tissue: a new perspective for thermal lesion detection. Phys Med Biol. 2025 Dec 29;71(1). doi: 10.1088/1361-6560/ae2bd8. PMID: 41380289
Wehrle CJ, Burns K, Mabud T, Ahmed AS, Alassas M, Juarez T, Ton J, Kim J, Aucejo F, Berber E, Ong E, Silk M, Hewitt B, Kwon DCH. Local Tumor Control of Liver Tumors After Histotripsy: A Preliminary National Multicenter Study. JCO Oncol Pract. 2025 Dec 16:OP2500550. doi: 10.1200/OP-25-00550. PMID: 41401400
Wong BO, Fan CM, Shyn PB, Wang J. Vascular complications following histotripsy of hepatocellular carcinoma. Int J Hyperthermia. 2025 Dec;42(1):2603108. doi: 10.1080/02656736.2025.2603108. Epub 2025 Dec 16. PMID: 41403239
Burns K, Juarez TM. Histotripsy for portal vein tumor thrombus in a patient with hepatocellular carcinoma: a case report. Front Oncol. 2025 Dec 2;15:1721814. doi: 10.3389/fonc.2025.1721814. eCollection 2025. PMID: 41409237
Gao Z, Yao L, Wei X, Wang S, Cao W, Deng W, Li X, Zhang Z, Wang S, Zhang Y, Li M, Xie Y. Progress in the Application of Nanobiotechnology in the Ablation Therapy of Hepatic Carcinoma. Int J Nanomedicine. 2025 Dec 15;20:15109-15133. doi: 10.2147/IJN.S551980. eCollection 2025. PMID: 41424453
Mundhava M, Vadodariya B, Jangid P, Shah A. Histotripsy Compared With Microwave Ablation, Radiofrequency Ablation, and Stereotactic Body Radiotherapy for the Treatment of Liver Tumors. Cureus. 2025 Dec 25;17(12):e100088. doi: 10.7759/cureus.100088. eCollection 2025 Dec. PMID: 41458348
Xie S, Ran L, Yang W, Zhou K, Jin C, Zhu H. Efficacy and safety of high-intensity focused ultrasound ablation under general anesthesia in older hepatocellular carcinoma patients. Front Oncol. 2025 Dec 11;15:1702332. doi: 10.3389/fonc.2025.1702332. eCollection 2025. PMID: 41458596
Haddad A, Vauthey JN. Are We Advancing Local Control of Liver Tumors With Histotripsy? Ann Surg. 2025 Dec 1;282(6):917-918. doi: 10.1097/SLA.0000000000006810. Epub 2025 Jun 25. PMID: 40560672
Song M, Thomas GPL, Khokhlova VA, Wang YN, Totten SI, Sapozhnikov OA, Schade GR, Khokhlova T. Doppler-based assessment of boiling histotripsy-induced volumetric tissue liquefaction in vivo. Ultrasonics. 2025 Dec;156:107775. doi: 10.1016/j.ultras.2025.107775. Epub 2025 Jul 29. PMID: 40752065
Mabud TS, Vergara M, Du J, Moore WH, Liu S, Bertino F, Taslakian B, Wolfgang C, Hewitt DB, Silk M. Histotripsy of Liver Metastases: Short-Term Safety and Imaging Findings. Cardiovasc Intervent Radiol. 2025 Nov;48(11):1594-1603. doi: 10.1007/s00270-025-04183-8. Epub 2025 Sep 28. PMID: 41016946
Chan AC, Lau VW, Wong GT, Chan YW, Man K, Ng LY, Ma H, Husain A, Ng IO. Prospective analysis on the outcomes of histotripsy for primary and metastatic liver tumours. Int J Surg. 2025 Nov 10. doi: 10.1097/JS9.0000000000003856. PMID: 41217432
Zhu Q, Ran R, Chen Q, Ren J, Qin Y, Zhang Y, Jiang M, Feng C, Zhu H, Shu S. Impact of valsalva maneuver duration on brain function in patients undergoing high-intensity focused ultrasound liver ablation: a randomized controlled trial. Int J Surg. 2025 Nov 13. doi: 10.1097/JS9.0000000000003885. PMID: 41231626
Jimenez-Soto C, Byrne MM, Loszko A, Endo Y, Nair A, Hernandez-Alejandro R, Oppenheimer D, Rubens D, Clark A, Bekki Y, Tomiyama K. First FDA approved experience with histotripsy for liver cancer management. Int J Surg. 2025 Nov 19. doi: 10.1097/JS9.0000000000004070. PMID: 41255274
Yeats E, Lu N, Sukovich J, Xu Z, Hall TL. Aberration correction expands the treatment envelope for histotripsy in the liver. Phys Med Biol. 2025 Nov 20. doi: 10.1088/1361-6560/ae222c. PMID: 41265042
Foltz GM, Kisting AL, Falk KL, Golden E, Laeseke P, Cho CS, Ziemlewicz T, Hinshaw JL, Koepsel EK, Lee FT Jr. An Emerging Paradigm Shift in Liver Ablation: The Potential for Clinical Impact of Nonthermal Ablation Technologies. J Vasc Interv Radiol. 2025 Dec;36(12):1868-1875. doi: 10.1016/j.jvir.2025.09.005. PMID: 41276365
Kim S, Majumdar A, Waters JP, Topper GV, Ghanem Y, Elbezanti W, Song S, Hong YK. Immunoresistant to immunosensitive – Histotripsy’s unique potential to overcome resistance. Crit Rev Oncol Hematol. 2025 Nov 27;217:105054. doi: 10.1016/j.critrevonc.2025.105054. PMID: 41317817
Ziemlewicz TJ, Critchfield JJ, Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Créixams X, Lubner M, Wah TM, Littler P, Davis CR, Narayanan G, White SB, Ahmed O, Collins ZS, Parikh ND, Planert M, Thormann M, Torzilli G, Solbiati LA, Cho CS. The #HOPE4LIVER Single-arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors: One-year Update of Clinical Outcomes. Ann Surg. 2025 Dec 1;282(6):908-916. doi: 10.1097/SLA.0000000000006720. Epub 2025 Apr 9. PMID: 40201962
Abu Zahra S, Nadeem A, Kundu A, Gibson N, Haggaz A, Sato KT, Lewandowski RJ, Gordon AC. Recent Advances in Ablative Therapies for Hepatocellular Carcinoma. Cancers (Basel). 2025 Oct 7;17(19):3251. doi: 10.3390/cancers17193251. PMID: 41097777
Kisting MA, Kisting AL, Kurichety SL, Couillard AB, Sorensen AM, Knott EA, White JK, Bradley CW, Falk KL, Hinshaw JL, Lubner MG, Swietlik JF, Wagner MG, Laeseke PF, Vlaisavljevich E, Lee FT Jr, Ziemlewicz TJ. Histotripsy of the hepatic capsule and the gastric wall: acute treatment effects in a swine model. Int J Hyperthermia. 2025 Dec;42(1):2572364. doi: 10.1080/02656736.2025.2572364. Epub 2025 Oct 22. PMID: 41122018
Song M, Thomas GPL, Khokhlova VA, Wang YN, Totten SI, Sapozhnikov OA, Schade GR, Khokhlova T. Doppler-based assessment of boiling histotripsy-induced volumetric tissue liquefaction in vivo. Ultrasonics. 2025 Dec;156:107775. doi: 10.1016/j.ultras.2025.107775. Epub 2025 Jul 29. PMID: 40752065
Xenos D, Sotirchos VS, Dimopoulos PM, Sofocleous CT. Interventional Oncology for Colorectal Liver Metastases: From Local Cure to Salvage Therapy. Biomedicines. 2025 Sep 6;13(9):2182. doi: 10.3390/biomedicines13092182. PMID: 41007745
Pallumeera M, Hong M, Giang JC, Makary MS. Histotripsy: Recent Advances, Clinical Applications, and Future Prospects. Cancers (Basel). 2025 Sep 19;17(18):3072. doi: 10.3390/cancers17183072. PMID: 41008913
Paramythiotis D, Tsavdaris D, Tsavdaris G, Hatzidakis A, Psarras K, Mekras A, Georgiades C, Michalopoulos A. Surgery Without Scalpel: Histotripsy as a Non-Invasive and Non-Thermal Modality for Liver Tumor Ablation. J Clin Med. 2025 Sep 10;14(18):6391. doi: 10.3390/jcm14186391. PMID: 41010594
Mabud TS, Vergara M, Du J, Moore WH, Liu S, Bertino F, Taslakian B, Wolfgang C, Hewitt DB, Silk M. Histotripsy of Liver Metastases: Short-Term Safety and Imaging Findings. Cardiovasc Intervent Radiol. 2025 Sep 28. doi: 10.1007/s00270-025-04183-8. PMID: 41016946
Berman ZT, Patel T, Burgoyne AM, Clary BM. Hyperprogression and Systemic Metastasis of Cholangiocarcinoma after Histotripsy Therapy. J Vasc Interv Radiol. 2025 Sep;36(9):1465-1466. doi: 10.1016/j.jvir.2025.06.002. PMID: 40846437
Ong ES, Wehrle CJ, Alassas MM. Use of Histotripsy to Rapidly Relieve Biliary Obstruction in a Patient With Recurrent Hilar Cholangiocarcinoma. Am Surg. 2025 Aug 28:31348251358442. doi: 10.1177/00031348251358442. PMID: 40876872
Winterholler JE, Kisting MA, Falk KL, Kisting AL, Jentink MS, White JK, Lubner MG, Laeseke PF, Knavel Koepsel EM, Swietlik JF, Hinshaw JL, Ferreira TH, Mao L, McCormick T, Cui M, Lee FT Jr, Ziemlewicz TJ. Hepatic Histotripsy: Jet Ventilation Decreases the Effect of Respiratory Motion in A Porcine Liver Model. Cardiovasc Intervent Radiol. 2025 Aug;48(8):1164-1173. doi: 10.1007/s00270-025-04060-4. Epub 2025 Jun 4. PMID: 40468037
Li H, Yin J, Dong X, He P, Huang L, Sun L, Liu Z. A Novel Sonoablation of Liver Tissue Based on Acoustic Droplet Vaporization: A Feasibility Study. Acad Radiol. 2025 Sep;32(9):5126-5136. doi: 10.1016/j.acra.2025.04.047. Epub 2025 Jun 12. PMID: 40514306
Raman AP, Kotlarz PL, Giff AE, Goundry KA, Laeseke P, Koepsel EMK, Alhamami M, Daye D. Breaking Barriers with Sound: The Implementation of Histotripsy in Cancer. Cancers (Basel). 2025 Aug 1;17(15):2548. doi: 10.3390/cancers17152548. PMID: 40805244
Wang S, Zhang Z, Sun L, Li J, Liu H, Huang X, Cui J, Zhu C, Wang S, Chen W, Qiu W. Clinical observation and immune effect of high-intensity focused ultrasound (HIFU) treatment on patients with colorectal cancer liver metastasis. Int J Hyperthermia. 2025 Dec;42(1):2519344. doi: 10.1080/02656736.2025.2519344. Epub 2025 Aug 14. PMID: 40814140
Fall F, Eisenbrey JR, Tam A, Contreras K, Maxwell A, Vlaisavljevich E, Liu JB, Kuon Yeng Escalante C, Siu Xiao T, Mohammed A, Forsberg F, Goldberg A, Koenig G. Contrast-enhanced ultrasound-guided high intensity focused ultrasound treatment of grade 4 liver lacerations in a swine model. J Trauma Acute Care Surg. 2025 Jul 4. doi: 10.1097/TA.0000000000004737. PMID: 40611378
Park JH, Heo J, Pahk K, Pahk KJ. A parametric study of bubble dynamics and lesion formation in liver tissue phantom during pressure-modulated shockwave histotripsy. Sci Rep. 2025 Jul 21;15(1):26387. doi: 10.1038/s41598-025-11512-x. PMID: 40691226
Hsiao WC, Yeh CL, Kao YJ, Chu SY, Hsieh BY. Spatiotemporal monitoring of tissue coagulation treated by continuous high-intensity focused ultrasound with pulse-inversion shear wave elastography. Ultrasonics. 2025 Jul 21;156:107766. doi: 10.1016/j.ultras.2025.107766. PMID: 40706513
Worlikar T, Loudon N, Khaykin VM, Zhang M, Cho CS, Hall T, Vlaisavljevich E, Fowlkes JB, Parikh ND, Xu Z, Mendiratta-Lala M. Development of Histotripsy as a Local-Regional Liver Cancer Therapy: Preclinical to Clinical Translation. Radiol Imaging Cancer. 2025 Jul;7(4):e240403. doi: 10.1148/rycan.240403. PMID: 40711384
Queen H, Ferris SF, Cho CS, Ganguly A. The Emerging Role of Histotripsy in Liver Cancer Treatment: A Scoping Review. Cancers (Basel). 2025 Mar 7;17(6):915. doi: 10.3390/cancers17060915. PMID: 40149252
Hubbard R, Choi D, Worlikar T, Scheven U, Kim H, Sukovich J, Hall TL, Xu Z. MRI Co-registered Rodent Histotripsy Array for Orthotopic Liver Models. IEEE Trans Ultrason Ferroelectr Freq Control. 2025 Mar 20;PP. doi: 10.1109/TUFFC.2025.3553083. PMID: 40111779
Glickstein B, Bismuth M, Gattegno R, Bercovici T, Shaul O, Aronovich R, Horn G, Levin AG, Feng Y, Ilovitsh T. Volumetric Nanodroplet-Enhanced Ultrasound Surgery Combined with Immune Checkpoint Inhibition as a Cancer Therapy Platform. Small. 2025 Mar 10:e2411474. doi: 10.1002/smll.202411474. PMID: 40059532
Cao J, Wang L, Li J, Song M, Zheng Y, He X, Li X, Xu S, Sun L. Bubble cloud-mediated cavitation for tumor mechanical ablation and effector immune cell deployment. Ultrason Sonochem. 2025 Mar 1;115:107296. doi: 10.1016/j.ultsonch.2025.107296. PMID: 40037140
Wagner MG, Minesinger GM, Falk KL, Kutlu AZ, Kisting MA, Speidel MA, Ziemlewicz TJ, Hinshaw JL, Swietlik JF, Lee FT Jr, Laeseke PF. Evaluation of targeting accuracy of cone beam CT guided histotripsy in an in vivo porcine model. Int J Hyperthermia. 2025 Dec;42(1):2455138. doi: 10.1080/02656736.2025.2455138. Epub 2025 Jan 22. PMID: 39842812
Tam A, Contreras K, Fall F, Maxwell A, Liu JB, Forsberg F, Vlaisavljevich E, Goldberg A, Xiao TS, Kuon Yeng Escalante C, Eisenbrey JR, Koenig G. Development of a contrast-enhanced ultrasound-guided high-intensity focused ultrasound system for coagulation of liver parenchyma. J Trauma Acute Care Surg. 2025 Apr 1;98(4):662-666. doi: 10.1097/TA.0000000000004397. Epub 2024 May 23. PMID: 38750641
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Uysal M, Wehrle CJ, Coppa C, Kamath S, Krishnamurthi S, Martin C, Hag ME, Khalil M, Fujiki M, Schlegel A, Miller C, Hashimoto K, Aucejo F, Kwon DC, Kim J. Bridging therapy with histotripsy prior to liver transplantation for hepatocellular carcinoma: a first case report. Exp Hematol Oncol. 2025 Feb 25;14(1):20. doi: 10.1186/s40164-025-00604-z. PMID: 40001149
Liao Y, Wang D, Yang X, Ni L, Lin B, Zhang Y, Feng G, Li J, Gao F, Liao M, Du X, Chen W. Highintensity focused ultrasound thermal ablation boosts the efficacy of immune checkpoint inhibitors in advanced cancers with liver metastases: A singlecenter retrospective cohort study. Oncol Lett. 2025 Jan 7;29(3):124. doi: 10.3892/ol.2025.14871. eCollection 2025 Mar. PMID: 39807097
Li H, Deng Q, Cai Z, Wang Q, Huang L, Gao Y, Dong X, Sun L, Liu Z. Ultrasound Erosion of Rabbit Liver Induced by Locally Injected Phase-Shift Acoustic Droplets and With Lauromacrogol. J Ultrasound Med. 2025 Jan 21. doi: 10.1002/jum.16650. PMID: 39835387
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Xiong X, Zhou H, Xu X, Fu Q, Wan Y, Cao Y, Tang R, Li F, Zhang J, Li P. Ultrasound Molecular Imaging Enhances High-Intensity Focused Ultrasound Ablation on Liver Cancer With B7-H3-Targeted Microbubbles. Cancer Med. 2024 Oct;13(20):e70341. doi: 10.1002/cam4.70341. PMID: 39431644
Ruger L, Langman M, Farrell R, Rossmeisl JH, Prada F, Vlaisavljevich E. Ultrasound-Guided Mechanical High-Intensity Focused Ultrasound (Histotripsy) Through an Acoustically Permeable Polyolefin-Based Cranioplasty Device. IEEE Trans Biomed Eng. 2024 Oct;71(10):2877-2888. doi: 10.1109/TBME.2024.3399688. Epub 2024 Sep 19. PMID: 38728123
Mendiratta-Lala M, Wiggermann P, Pech M, Serres-Créixams X, White SB, Davis C, Ahmed O, Parikh ND, Planert M, Thormann M, Xu Z, Collins Z, Narayanan G, Torzilli G, Cho C, Littler P, Wah TM, Solbiati L, Ziemlewicz TJ. The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors. Radiology. 2024 Sep;312(3):e233051. doi: 10.1148/radiol.233051. PMID: 39225612
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